Senior Regulatory Affairs Specialist
4 tygodni temu
Senior Regulatory Specialist, CTA/IND
We are seeking a highly skilled Senior Regulatory Specialist to join our Polish Hub. This role will be responsible for coordinating, developing, and refining the CTA/IND lifecycle strategy, ensuring timely content delivery and compliance with GSK policy and procedures.
Key Responsibilities:
- Develop and implement the CTA/IND lifecycle strategy, ensuring compliance with regulatory requirements and GSK policies.
- Coordinate with cross-functional teams to ensure timely content delivery and submission to regulatory agencies.
- Accountable for ensuring the quality of work and delivery of projects to agreed timeframes.
- Provide input to internal processes and written standards.
- Work flexibly to meet shifting priorities and timelines.
Requirements:
- Min. Bachelor's degree in biological or healthcare science.
- Relevant experience within Regulatory Affairs in the R&D, pharmaceutical industry or clinical trials.
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Excellent organizational skills, attention to detail, and commitment to deliver high-quality output.
- Ability to work in multiple IT systems and lead in a matrix environment.
What We Offer:
- Contract of employment.
- Hybrid work (2/3 days per week from the office).
- Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit).
- Life insurance and pension plan.
- Private medical package with additional preventive healthcare services for employees and their eligible.
- Sports cards (Multisport).
- Possibilities of development within the role and company's structure.
- Personalized learning approach (internal trainings, mentoring, access to online training' platforms).
- Extensive support of work-life balance (flexible working solutions, short Fridays option, health & well-being activities).
- Supportive community and integration events.
-
Regulatory Affairs Specialist
4 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatRegulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our international Regulatory Affairs Team. As a key member of the team, you will be responsible for coordinating lifecycle management procedures, ensuring timely submission of high-quality dossiers, and managing validation issues.Key Responsibilities:Coordinate...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska Novo Nordisk Pełny etatJob Description:Novo Nordisk is seeking a highly skilled Regulatory Affairs Specialist to join our team in Poland. As a key member of our Regulatory and Pharmacovigilance Team, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA). Your main responsibilities...
-
Regulatory Affairs Specialist
4 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatJob DetailsWe are seeking a skilled Regulatory Affairs Specialist to join our international team at Randstad Polska.About the RoleThe ideal candidate will have experience in regulatory affairs data management within the pharmaceutical or cosmetics industry. Strong knowledge of English and Polish is essential, with a good understanding of pharmaceutical...
-
Senior Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska Allegro sp. z o.o. Pełny etatKey ResponsibilitiesAs a Senior Regulatory Affairs Specialist at Allegro sp. z o.o., you will play a crucial role in shaping critical legislation for our company and the CEE region. Your primary responsibilities will include monitoring legislative proposals, developing analytical documents to facilitate engagement, and implementing significant legal...
-
Regulatory Affairs Specialist
4 tygodni temu
Warszawa, Mazovia, Polska Novo Nordisk Pełny etatJob SummaryAs a Regulatory Affairs Specialist at Novo Nordisk, you will be responsible for handling Regulatory Affairs documentation related to Product Life Cycle Management (LCM) and/or New Drug Applications (NDA).Key Responsibilities:Preparing and submitting Regulatory documentation for New Drug Applications, post-marketing variations and renewal...
-
Regulatory Affairs Specialist
4 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatAre you looking for a challenging role in the pharmaceutical industry? We are seeking a highly skilled Regulatory Affairs Specialist to join our international Regulatory Affairs Team.Key responsibilities:Perform regulatory data entry activitiesTrack incoming data entry requests and follow up until completionEnter data in relevant systems based on information...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska Boston Scientific Pełny etatKey Responsibilities:We are seeking an experienced Regulatory Affairs Specialist to join our team. The ideal candidate will have 2 years of experience in a similar role, with a strong understanding of EU and non-EU regulatory requirements.Responsibilities:Plan and prioritize product notification/registration for EU and non-EU countries.Prepare and submit...
-
{"text":"Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etat{"text":"Job Title: Regulatory Affairs Specialist (Pharmaceutical Industry)Are you looking for a role that combines your passion for regulatory affairs with your experience in the pharmaceutical industry?We are currently seeking a Regulatory Affairs Specialist to join our team at Randstad Polska.Employment contract for 12 months with the possibility of...
-
Regulatory Affairs Specialist ds. Rejestracji Leków
3 tygodni temu
Warszawa, Mazovia, Polska IT Performance Pełny etatStanowisko Senior Regulatory Affairs SpecialistPoszukujemy kandydata na stanowisko Senior Regulatory Affairs Specialist do pracy w oparciu o UoP. Praca i zatrudnienie jest dedykowane dla naszego klienta - rozpoznawalnej firmy z obszaru farmacji/medycyny.Obowiązki:Koordynowanie i przygotowywanie wniosków regulacyjnych w celu rejestracji surowca...
-
Regulatory Affairs Expert
3 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatJob DescriptionIntroductionRandstad Polska is seeking an experienced Regulatory Affairs Specialist to join their international Regulatory Affairs Team. The successful candidate will be responsible for coordinating lifecycle management procedures and ensuring timely submission of high-quality dossiers.Key ResponsibilitiesCoordinate lifecycle management...
-
Regulatory Affairs Specialist
1 miesiąc temu
Warszawa, Mazovia, Polska Parexel Pełny etatParexel is seeking a Regulatory Affairs Associate (Labelling) to support our team.The successful candidate will be responsible for managing and coordinating text and artwork changes, ensuring compliance with regulatory requirements and global labeling standards.Key Responsibilities:Track the status of ongoing changes to labelling/artwork projects, evaluating...
-
Regulatory Affairs Professional
4 tygodni temu
Warszawa, Mazovia, Polska RICG Poland Sp. z o.o. Pełny etatRegulatory Affairs Specialist RoleWe are seeking a highly motivated individual with a background in Polish and European regulatory law to support our team in delivering high-quality pharmaceutical products.Key Responsibilities:Ensure compliance with Polish and European regulations for pharmaceutical products.Liaise with internal departments and external...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska Parexel Pełny etatWork with Us to Shape the Future of Clinical ResearchParexel, a leading Clinical Research Organization, is currently seeking a skilled and detail-oriented Regulatory Affairs Associate (Labelling) to join our team.As a Regulatory Affairs Associate, you will be responsible for managing and coordinating text and artwork changes, ensuring compliance with...
-
Senior Regulatory Affairs Specialist
1 miesiąc temu
Warszawa, Mazovia, Polska Allegro sp. z o.o. Pełny etatJob DescriptionAllegro Group is seeking a Senior Regulatory Affairs Specialist to join our Regulatory Affairs team focused on Poland and the CEE region. In this role, you will be instrumental in shaping critical legislation, including postal, customs, logistics, and tax laws, as well as AI and tech-related legislation. You will monitor legislative proposals,...
-
Regulatory Affairs Specialist
3 tygodni temu
Warszawa, Mazovia, Polska 9605 GSK Services Sp z o.o. Pełny etatAbout the Role:We are seeking a Senior Regulatory Specialist to join our Polish Hub at 9605 GSK Services Sp z o.o. This role will play a critical part in the development, refinement, and coordination of the CTA/IND lifecycle strategy, ensuring timely content delivery and compliance with GSK policy and procedures.Key Responsibilities:Develop and refine the...
-
Regulatory Affairs Data Management Specialist
2 tygodni temu
Warszawa, Mazovia, Polska Randstad Polska Pełny etatJob DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our international team at Randstad Polska. This role involves working closely with our clients in the pharmaceutical industry, providing expertise in regulatory affairs data management.Company OverviewOur client is an international company from the pharmaceutical industry,...
-
Regulatory Affairs Specialist
4 tygodni temu
Warszawa, Mazovia, Polska Boston Scientific Pełny etatJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Boston Scientific. As a key member of our regulatory team, you will be responsible for planning and prioritizing product notification/registration for various countries, preparing and submitting regulatory applications, and maintaining active knowledge of product...
-
Regulatory Affairs Specialist
1 miesiąc temu
Warszawa, Mazovia, Polska ManpowerGroup Sp. z o.o. Pełny etatRegulatory Affairs ProfessionalManpower Group Sp. z o.o. is a global company with over 70 years of experience, operating in 82 countries. We have been present on the Polish market since 2001 and currently have almost 35 branches across the country. Our goal is to provide candidates with new opportunities, help them find a job that matches their...
-
Regulatory Affairs Specialist
1 miesiąc temu
Warszawa, Mazovia, Polska 9605 GSK Services Sp z o.o. Pełny etatJob Title: Regulatory Specialist We are seeking a highly skilled Regulatory Specialist to support our operational activities related to the maintenance of marketing authorizations (MAs) across assigned markets and/or submission types in European Partnership Markets.Key Responsibilities:Support country leads in activities related to MA maintenance for...
-
Regulatory Affairs Specialist
2 tygodni temu
Warszawa, Mazovia, Polska Boston Scientific Pełny etatUnlock Your Potential in Medical ScienceBoston Scientific, a leader in medical science for over 40 years, offers an exciting opportunity for a Regulatory Affairs Specialist to join our team. With a deep commitment to advancing science for life, we're looking for a skilled professional to help us tackle the challenges that matter most.About the Role:This is...